Implants can be used to augment particular areas of the human body, such as calves, breasts and others. Implantation of implants can be used for reconstructive purposes or cosmetic purposes. For breast implants, reconstructive implantation purposes can include implantation after mastectomy for breast cancer, where a woman has had one or both breasts removed, while cosmetic reasons for implantation can include to change the size, firmness, or shape of the breast or for other aesthetic reasons.
Current breast implants include saline implants and silicone implants. Saline implants can include silicone shells filled with sterile salt water such as saline. Silicone implants can include silicone shells filled with silicone gel. Implantation procedures typically involve a surgeon making an incision under the breast, under the arm or around the nipple and then implanting the implant into a pocket or capsule above or below the chest muscle. The surgeon then closes the incisions with sutures.
Previously contemplated methods involving breast implant devices using Gore-Tex and expanded polytetrafluoroethylene, also known as ePTFE, and Teflon have not been widely implemented for various reasons as described in the prior art but would have many beneficial properties. These reasons are variously described, as follows:
Previous patents that have used ePTFE as an outer layer coating have generally done so in order to create textured surfaces that try to encourage tissue ingrowth from surrounding tissues. U.S. Pat. Nos. 8,647,393; 8,372,423; and 5,779,734 which are incorporated herein in their entirety by reference are examples of such ingrowth embodiments. As described in the stated goal of the U.S. Pat. No. 8,647,393: “[d]isclosed herein are implantable devices coated with microporous surface layers with macrotopographic features that improve bio-integration at the interface of the implantable devices and the surrounding tissue.”
A recent non-patent reference states that “[a]fter multiple experimental and clinical trials, there seems to be a strong consensus that the use of textured outer shell surfaces, in comparison with smooth surfaces, is able to decrease the incidence of capsular contracture by disrupting contractile forces around the implant, emphasizing the need for better physical properties than cellular or pharmacological strategies of contracture formation.” Capsular Contracture by silicone breast implants: possible causes, biocompatibility, and prophylactic strategies, Steiert A E et al, Med Devices (Auckl) 2013; 6:211-218, which is hereby incorporated in its entirety by reference.
Another paper, published in November 1963 and titled Teflon-Silicone Implants by Benjamin Edwards, MD described the use of “Teflon felt” over a silicone implant because “[t]he following characteristics of an ideal breast implant are well known to every plastic surgeon. Such an implant . . . should become firmly attached to body tissues.” Plastic and Reconstructive Surgery November 1963; Vol. 32, No. 5, pp 519-526, which is hereby incorporated in its entirety by reference. The author further stated that in his opinion “[i]t is most important to have some sort of rough surface on the outside . . . . As we have used here, a layer of Teflon foam.”
As described above, the state of the art is that rough outer surfaces are desirable on implants in order to increase capsular formation and promote direct bio-integration of implants with their surrounding tissue. However, as described herein and opposite and distinct from the prior art goals, methods, and devices, it can be beneficial to prevent direct bio-integration between an implant and its surrounding tissue. In such cases, creation of an intima, bursa and synovial fluid environment or combinations thereof, in which an implant is not held in rigid position by a capsule and where an implant may or may not have an outer layer of cellular growth can provide unique and heretofore unknown benefits over the current state of the art.
Further, use of novel materials which have not previously been applied to implants because of their compositions and difficulty in bonding with silicone, are disclosed. Another paper, published in May 2014 and titled The Pocket Protector: A New e-PTFE Breast Implant Device by Mark Berman, MD, states that “E-PTFE is considered one of the safest synthetic implant materials. Nonetheless, e-PTFE does not have the elastic properties of silicone rubber and would not serve well as a coating on the implant.” Amer. Soc. of Cosmetic Breast Surgery 31st Annual Workshop May 1-4, 2015, which is hereby incorporated in its entirety by reference. As such, the state of the art is that it teaches away from using e-PTFE as a coating on an implant because of its less elastic character than silicone rubber despite its known advantageous properties of being safe. Further, while coupling an ePTFE layer and silicone layer at an interface has been attempted in the past, it has achieved only minimal success without commercial viability, but newer methods of linking, adhering, gluing, or otherwise coupling ePTFE and silicone together can improve bio-acceptance as well as provide numerous other benefits.
Thus, as described herein and different from prior methods and breast implant devices, creation of an exterior implant surface that is not rough or textured and does not promote tissue integration at the implant surface and having the various advantages provided by materials such as ePTFE would be beneficial.